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Trial Title:
Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study
NCT ID:
NCT01498055
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
lung cancer
CIK cells
therapy
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Summary:
To study the efficacy and safety of autologous CIK cells infusion for the treatment of
lung cancer.
Detailed description:
A randomized controlled trail on the efficacy and safety of autologous cytokine-induced
killer (CIK) cells infusion treatment in advanced primary lung cancer
Criteria for eligibility:
Study pop:
Primary lung cancer diagnosis (including small cell lung cancer, lung adenocarcinoma,
lung squamous cell carcinoma and large cell carcinoma) patients
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 18~70 year old, KPS score >50 points, estimate survival > 3 months;
- Primary lung cancer patients after chemotherapy or radiation therapy;
- Primary lung cancer patients after targeted therapy;
- Primary lung cancer patients with lung function can not accept operation or
unwilling to operation;
- Primary lung cancer recurrence or surgery can't complete resection;
- Primary lung cancer patients after intervention therapy(I125 implanted, freezing,
rf, etc.);
- No serious mental illness and no serious heart, liver, kidney diseases,
unincorporated other potentially lethal diseases;
- Patients Voluntary attempt, and informed consent.
Exclusion Criteria:
- History of cardiovascular disease: congestive heart failure > New York heart
association (NYHA) level II, unstable angina patients (resting when the angina
symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of
myocardial infarction;
- Cachexia; or other deadly diseases;
- Liver function laboratory ALT, AST more than normal limits on 2.0 times ; Or kidney
TBIL, BUN more than normal limits on 1.0 times , or Cr more than normal upper limit;
- Active infection;
- Pregnant or lactating women
- At present Is receiving other cancer treatment (such as chemotherapy, radiation
therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents);
- Now or recently will join another experimental clinical study ;
- Other situations that the researchers considered unsuitable for this study (such as
mental illness, drug abuse, HIV infections, etc.), or influence on the results of
clinical trials for analysis.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Liang Gong
Address:
City:
Chong Qing
Zip:
400038
Country:
China
Status:
Recruiting
Contact:
Last name:
Liang Gong
Phone:
13983965893
Email:
gonglw1@gmail.com
Investigator:
Last name:
Liang Gong
Email:
Sub-Investigator
Start date:
December 2011
Completion date:
December 2013
Lead sponsor:
Agency:
Third Military Medical University
Agency class:
Other
Source:
Third Military Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01498055
